Generic name: ; LEVONORGESTREL 0.1mg, ETHINYL ESTRADIOL 0.02mg
Dosage form: tablets
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To achieve maximum contraceptive effectiveness, DELYLA™ (levonorgestrel and ethinyl estradiol tablets, USP) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of DELYLA is one white tablet daily for 21 consecutive days, followed by one yellow inert tablet daily for 7 consecutive days, according to the prescribed schedule. It is recommended that DELYLA be taken at the same time each day.
The possibility of ovulation and conception prior to initiation of medication should be considered. The patient should be instructed to begin taking DELYLA on either the first Sunday after the onset of menstruation (Sunday Start) or on Day 1 of menstruation (Day 1 Start).
The patient is instructed to begin taking DELYLA on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 21 consecutive days, followed by one yellow inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within 3 days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle, contraceptive reliance should not be placed on DELYLA until a white tablet has been taken daily for 7 consecutive days, and a nonhormonal back-up method of birth control should be used during those 7 days.
During the first cycle of medication, the patient is instructed to begin taking DELYLA during the first 24 hours of her period (day one of her menstrual cycle). One white tablet should be taken daily for 21 consecutive days, followed by one yellow inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within 3 days following discontinuation of white tablets and may not have finished before the next pack is started. If medication is begun on day one of the menstrual cycle, no back-up contraception is necessary. If DELYLA tablets are started later than day one of the first menstrual cycle or postpartum, contraceptive reliance should not be placed on DELYLA tablets until after the first 7 consecutive days of administration, and a nonhormonal back-up method of birth control should be used during 7 days.
The patient begins her next and all subsequent courses of tablets on the day after taking her last yellow tablet. She should follow the same dosing schedule: 21 days on white tablets followed by 7 days on yellow tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a nonhormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.
When the patient is switching from a 21–day regimen of tablets, she should wait 7 days after her last tablet before she starts DELYLA. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21–day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of DELYLA on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin DELYLA the next day. If switching from an implant or injection, the patient should start DELYLA on the day of implant removal or, if using an injection, the day the next injection would be due. In switching from a progestin-only pill, injection, or implant, the patient should be advised to use a nonhormonal back-up method of birth control for the first 7 days of tablet-taking.
If spotting or breakthrough bleeding occur, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician.
While there is little likelihood of ovulation occurring if only one or two white tablets are missed, the possibility of ovulation increases with each successive day that scheduled white tablets are missed. Although the occurrence of pregnancy is unlikely if DELYLA is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.
The risk of pregnancy increases with each active (white) tablet missed. For additional patient instructions regarding missed tablets, see the WHAT TO DO IF YOU MISS PILLS section in the DETAILED PATIENT LABELING below.
DELYLA may be initiated no earlier than day 28 postpartum in the nonlactating mother or after a second trimester abortion due to the increased risk for thromboembolism (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS concerning thromboembolic disease). The patient should be advised to use a non-hormonal back-up method for the first 7 days of tablet taking.